Back to resultsCellMist™ Autologous Cells to Treat Deep Second-Degree Burns (CELLMIST1)
Primary Purpose
Burns, Burns Second Degree, Burns Deep Second Degree
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CellMist™ System
Sponsored by
About this trial
This is an interventional treatment trial for Burns focused on measuring Cell Therapy, Burn Injury
Eligibility Criteria
Inclusion Criteria:
- Is between 18 and 65 years of age inclusive;
- Has at least one discrete deep second degree (II°B) thermal burn injury (≤ 30% Total Body Surface Area (TBSA)) that requires surgical or enzymatic debridement and split thickness skin grafting (STSF) on any body surface excluding the face, joints, perineum and hands;
- Agrees to abstain from any other surgical treatment of the wound(s) for the duration of the study unless determined by the Principal Investigator to be medically necessary;
- Treatment with CellMist™ occurs with 7 days of burn injury;
- Demonstrates (as determined by the Principal Investigator) the ability and willingness to follow the requirements of the protocol;
- Understand the full nature and purpose of the study and provides voluntary written informed consent -
Exclusion Criteria:
- Is pregnant or does not agree to use acceptable contraception methods for the duration of their participation in the clinical trial (latter applies to women and men of child bearing potential);
- Is breast feeding;
- Has a pre-existing local and/or systemic bacterial infection that requires antibiotic treatment for more than 2 days prior to study treatment;
- Demonstrates an anesthesia risk that (as determined by the Principal Investigator) prohibits treatment
- Body Mass Index (BMI) ≥ 39;
- The burn(s) at the target treatment area(s) results from chemical, electrical or radiation exposure;
- Has full thickness (III°) burns TBSA ≥ 20%
- Has comorbidities and/or medications and/or health status that (as determined by the Principal Investigator) could result in poor cell isolation and/or poor wound healing (e.g., uncontrolled and/or significant diabetes (≥8% HbA1c by medical record), peripheral vascular disease, active malignancy or treatment (other than surgery) of malignancy within the past 3 months, autoimmune disease, renal failure (glomerular filtration rate <60mL/minute) and/or systemic steroid usage);
- Known hypersensitivities to trypsin, collagenase, or GentLyase (dispase);
- Has a medical condition that would make life expectancy < 12 months;
- Is currently participating in another prospective investigational clinical trial;
- Does not agree to abstain from enrolling in any other study for the duration of this study;
- Gram staining of SkinGun™ cell suspension output shows excessive microbial bioburden (≥ 200 microbial particles/field)
Sites / Locations
- Washington MedStar Hospital
Outcomes
Primary Outcome Measures
All Adverse Events
All Adverse Events will be reported, recorded and analyzed which occur from the time Informed Consent is given through the conclusion of the study. We will be looking at ; Incidence, Severity, Expectedness, Duration, Treatment, and the Relationship to Device for each Adverse Event reported.
Secondary Surgical Interventions
We will be evaluating and analyzing all secondary surgical interventions required to treat the intended target wound. A secondary surgical intervention may include debridement, biopsy, identification of an infectious pathogen, split thickness skin graft, etc...
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04890574
Brief Title
CellMist™ Autologous Cells to Treat Deep Second-Degree Burns
Acronym
CELLMIST1
Official Title
An Open Label Pilot Study to Evaluate the CellMist™ System in the Treatment of Deep Second Degree (IIoB) Burn Injuries With Autologous Skin Cells
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenovaCare, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The overall purpose of this study is to evaluate the safety of the CellMist™ System in the treatment of deep second degree burns (II°B) in a prospective, multicenter, feasibility pilot study.
Detailed Description
Patients between the ages of 18 and 65 years of age inclusive with a ≤ 30% Total Body Surface Area (TBSA) that requires surgical or enzymatic debridement and split thickness skin grafting (STSG) on any body surface excluding the face, joints, perineum and hands will be considered for participation in this study. CellMist™ solution (autologous epidermal and dermal cells) will be administered, via the System Skin Gun™, will be evenly distributed to aid in burn healing. Healing, pain and treatment-related adverse events will be evaluated at follow-up visits. Data concerning safety of the CellMist™ System will be collected. Safety will be evaluated in terms of treatment and serious related adverse events.
Each subject will participate in up to 9 total visits (screening, treatment and 7 follow-up study visits) over a period of 52 weeks. Up to 14 subjects will be enrolled and treated within this at up to 4 institutions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Burns Second Degree, Burns Deep Second Degree
Keywords
Cell Therapy, Burn Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective, single arm, open label non-randomized safety and device feasibility study.
Masking
None (Open Label)
Masking Description
This is a prospective, single arm, open label non-randomized safety and device feasibility study.
Allocation
Non-Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
CellMist™ System
Intervention Description
Open Label, Safety and Feasibility
Primary Outcome Measure Information:
Title
All Adverse Events
Description
All Adverse Events will be reported, recorded and analyzed which occur from the time Informed Consent is given through the conclusion of the study. We will be looking at ; Incidence, Severity, Expectedness, Duration, Treatment, and the Relationship to Device for each Adverse Event reported.
Time Frame
We will be evaluating all adverse events reported for the period from enrollment through the final visit which will be 12 months
Title
Secondary Surgical Interventions
Description
We will be evaluating and analyzing all secondary surgical interventions required to treat the intended target wound. A secondary surgical intervention may include debridement, biopsy, identification of an infectious pathogen, split thickness skin graft, etc...
Time Frame
The evaluation will include all reported secondary surgical interventions for the period from enrollment and up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Is between 18 and 65 years of age inclusive;
Has at least one discrete deep second degree (II°B) thermal burn injury (≤ 30% Total Body Surface Area (TBSA)) that requires surgical or enzymatic debridement and split thickness skin grafting (STSF) on any body surface excluding the face, joints, perineum and hands;
Agrees to abstain from any other surgical treatment of the wound(s) for the duration of the study unless determined by the Principal Investigator to be medically necessary;
Treatment with CellMist™ occurs with 7 days of burn injury;
Demonstrates (as determined by the Principal Investigator) the ability and willingness to follow the requirements of the protocol;
Understand the full nature and purpose of the study and provides voluntary written informed consent -
Exclusion Criteria:
Is pregnant or does not agree to use acceptable contraception methods for the duration of their participation in the clinical trial (latter applies to women and men of child bearing potential);
Is breast feeding;
Has a pre-existing local and/or systemic bacterial infection that requires antibiotic treatment for more than 2 days prior to study treatment;
Demonstrates an anesthesia risk that (as determined by the Principal Investigator) prohibits treatment
Body Mass Index (BMI) ≥ 39;
The burn(s) at the target treatment area(s) results from chemical, electrical or radiation exposure;
Has full thickness (III°) burns TBSA ≥ 20%
Has comorbidities and/or medications and/or health status that (as determined by the Principal Investigator) could result in poor cell isolation and/or poor wound healing (e.g., uncontrolled and/or significant diabetes (≥8% HbA1c by medical record), peripheral vascular disease, active malignancy or treatment (other than surgery) of malignancy within the past 3 months, autoimmune disease, renal failure (glomerular filtration rate <60mL/minute) and/or systemic steroid usage);
Known hypersensitivities to trypsin, collagenase, or GentLyase (dispase);
Has a medical condition that would make life expectancy < 12 months;
Is currently participating in another prospective investigational clinical trial;
Does not agree to abstain from enrolling in any other study for the duration of this study;
Gram staining of SkinGun™ cell suspension output shows excessive microbial bioburden (≥ 200 microbial particles/field)
Facility Information:
Facility Name
Washington MedStar Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
CellMist™ Autologous Cells to Treat Deep Second-Degree Burns
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